Intrauterine Inflated Foley's Catheter Balloon Plus Intravenous Tranexamic Acid During Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Participants with postpartum hemorrhage
研究概览
简要总结
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). The Bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. It has been used in cases of uterine atony and placenta previa with a success rate of 90%. However, Bakri balloon is not available in all countries.
The aim of this study is to evaluate the efficacy of the use of intrauterine inflated Foley's catheter balloon with or without intravenous tranexamic acid to control PPH during cesarean delivery in cases of placenta previa.
详细描述
Eligible participants were allocated to one of two groups. Group (I): patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. Group (II): patients received 1 gm tranexamic acid (TA), (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus Intrauterine Inflated Foley's Catheter Balloon. In group I, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. Neither the surgeon nor the anesthetist will know the nature of the IV administered drug before cesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa
排除标准
- •Patients with a cardiac, hepatic, renal or thromboembolic disease
- •patients with the high possibility of the morbid adherent placenta
- •known coagulopathy or thromboembolic disease
- •those presented with severe antepartum hemorrhage
- •hypersensitivity or contraindications of use of tranexamic acid
- •patient refuses to consent
研究组 & 干预措施
Foley's Catheter plus TA
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus 1 gm tranexamic acid in 100ml saline intravenous just before skin incision
干预措施: Foley's Catheter (Procedure)
Foley's Catheter plus TA
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus 1 gm tranexamic acid in 100ml saline intravenous just before skin incision
干预措施: TA (Drug)
Foley's Catheter plus placebo to TA
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus single injection of 100 ml intravenous saline before skin incision
干预措施: Foley's Catheter (Procedure)
Foley's Catheter plus placebo to TA
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus single injection of 100 ml intravenous saline before skin incision
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with postpartum hemorrhage
时间窗: 24 hours post operative
number of participant with blood loss \> 1000ml
次要结局
- intraoperative blood loss(during the operation)
- The number of participant needed for blood transfusion(24 hours postoperative)
- number of participant need of extra surgical maneuvers(24 hours post operative)
研究者
hany farouk
Principal Investigator
Aswan University Hospital